The pharmaceutical company has approached the US Food and Drug Administration (FDA) so it can start selling vaccines before the end of the year. At the same time, the pharmaceutical company has already started similar proceedings with the EU and the UK. CEO: "Our mission to provide a safe and effective vaccine has never been more urgent"
Pfizer announced today (Friday) that it has asked the United States Food and Drug Administration (FDA) to grant it an emergency permit that will allow it to start marketing corona virus vaccines starting next month.
The announcement comes days after the company, which worked on the vaccine together with its German partner BioNTech, announced that in its experiment, the vaccine had reached 95% efficacy.
The two companies said that the safety data of the experiment justify an emergency certificate, which the administration can grant even before the experiment in the vaccine has reached its complete end. In addition to FDA approval, companies have also begun to obtain approvals from Europe and the UK. "Our mission to provide a safe and effective vaccine has never been more urgent," said company CEO Albert Burla.
Submitting the application will lead to a chain of tests at the end of which the administration will have to decide whether the experiments are ready for use. If so, another division of government will need to consider how to plan the distribution of trials across the United States. In case the vaccine is approved, about 25 million doses of the vaccine are expected to be received as early as December, another 30 million doses in January and 35 million in February and March. Each vaccinated person will be required to receive two doses of the vaccine three weeks apart.
In early December, FDA scientific advisers are expected to hold a public hearing on the vaccine, and a few days earlier they are expected to present all their reservations about it. The advisors' recommendation should not only address whether or not to approve the vaccine, but also for which age groups and risk groups. Finally, they will vote on whether to approve it or not.
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